The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors (RESTORE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Examine PNF-induced changes in cognitive function as compared to the HED-Only control condition.
研究概览
简要总结
The investigators are interested in finding out how Prolonged Nightly Fasting (PNF) and/or health education may impact health and cancer recovery for breast cancer patients and survivors.
详细描述
The purpose of this innovative, remotely-delivered pilot randomized controlled trial (RCT) is to explore the use of an 8-week prolonged nightly fasting (PNF) intervention, as compared to a Health Education-Only (HED-Only) control condition, among ethnically and racially diverse (≥50% Black, Hispanic, and/or Native American) breast cancer survivors (BCSs) with cancer-related cognitive impairment (CRCI) to examine changes in cognitive function, sleep, insomnia and health-related quality of life (i.e., mental and physical). Additionally, intervention feasibility will be assessed among the PNF participants. All participants will receive health education (HED) throughout. BCSs living with CRCI (N=60) will be recruited nationwide and randomized 1:1 into the PNF or HED-Only groups. Linear mixed models will be used to compare outcome changes in the PNF group compared to HED-Only group (Aims 1-3); descriptive and qualitative analyses will be used in the Exploratory Aim.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Statistician will also be masked to condition
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •diagnosed with breast cancer (all stages included)
- •≥3 months post neoadjuvant or adjuvant chemotherapy (maintenance or palliative systemic therapy is included)
- •score ≤30 or lower on the Patient Reported Outcome Measurement Information System Cognitive Function Short Form 8a (sr-CRCI)
- •able to speak/understand English
- •have access to a computer and Wi-Fi
- •live within the United States
- •Identifies as female
- •willing and able to fully participate in the study
排除标准
- •type 1 diabetes
- •actively enrolled in formal diet/weight loss program
- •previous bariatric surgery
- •eating disorder history
- •night shift work
- •pregnant, breast feeding, or trying to get pregnant
- •dementia, psychological, psychiatric, or neurological diagnoses
- •active brain or central nervous system disease
- •prior or current use of memory enhancing medications
- •history or current brain radiation
- •frequently fasting for 12+ hours every night
- •13) history of hypoglycemia 14) depression screening on PHQ9 with a score of 20 or greater across all 9 questions OR anything other than 0 on question 9
研究组 & 干预措施
Prolonged Nightly Fasting and Health Education Videos
Participants in the Prolonge + HED condition will receive both the Prolonged Nightly Fasting and the Health Education Video interventions.
干预措施: Prolonged Nightly Fasting (Behavioral)
Prolonged Nightly Fasting and Health Education Videos
Participants in the Prolonge + HED condition will receive both the Prolonged Nightly Fasting and the Health Education Video interventions.
干预措施: Health Education Videos (Behavioral)
Health Education Videos Only
Participants in the Health Education Only condition will participate in only the Health Education Video intervention. Investigators will provide materials about Prolonged Nightly Fasting to these participants at the end of the study.
干预措施: Health Education Videos (Behavioral)
结局指标
主要结局
Examine PNF-induced changes in cognitive function as compared to the HED-Only control condition.
时间窗: Baseline (T1) and 8-week end point (T2) data collection
The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) will be used to assess subjective cognitive function using a scale of 0-156
次要结局
- Examine PNF-induced changes in sleep (i.e., duration, quality) and insomnia as compared to the HED-Only Control condition.(Baseline (T1) and 8-week end point (T2) data collection)
- Examine PNF-induced changes in quality of life as compared to the HED-Only Control condition.(Baseline (T1) and 8-week end point (T2) data collection.)
研究者
Dorothy Sears
Executive Director and Professor
Arizona State University